The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, evidence of clinical use, tissue build up and an indention on the teflon pad was identified.During activation, the device emitted a hissing noise.The device was disassembled.Dried fluid was observed in the handle pieces.The distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which allow fluid/tissue to rise up the rod.A review of the dhr supports that the device met all inspection and test criteria prior to release (e.G.Specific visual inspection of the distal gasket).The most likely root cause of the reported event was distal gasket damage.The most likely root cause of distal damage is tissue/fluid buildup and inadequate cleaning.The tissue/fluid buildup observed between the distal gasket and external shaft could have applied pressure to the distal gasket during activation and contributed to the damage seen to the distal gasket.The instructions for use (ifu) state: - the instruments allow for the coagulation of vessels up to and including 5mm in diameter.Do not attempt to seal vessels in excess of 5mm in diameter.- care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message.- blood and tissue buildup between the blade and the shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.- select the desired minimum power level using the increase and decrease buttons on the generator touchscreen.Note: the recommended minimum starting power level is level 3.For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level.The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type pathology, and surgical technique.- if tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged.The reported event will continue to be monitored through post-market surveillance.
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It was reported when the harmonic scalpel was activated, a sizzling/hissing sound was coming from the cord connection location on the device.The device was replaced.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
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